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The role of real-world evidence in health technology assessment decision-making: methodological challenges and recommendations from international health systems - a systematic literature review

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The incorporation of Real-World Evidence (RWE) into the decision-making processes of Health Technology Assessment (HTA) has gained increasing prominence as healthcare systems strive to evaluate interventions beyond the confines of controlled clinical trial environments. Nevertheless, methodological obstacles such as data quality, heterogeneity, and congruence with traditional evidence frameworks persistently hinder the effective utilisation of RWE. This systematic literature review investigates these challenges and evaluates the strategies employed by international health systems, including the National Institute for Health and Care Excellence (NICE), the Institute for Quality and Efficiency in Health Care (IQWiG), and the Haute Autorité de Santé (HAS), to address them. By identifying exemplars of established best practices and innovative frameworks, this study offers actionable recommendations aimed at enhancing the robustness, transparency, and applicability of RWE within HTA decision-making.

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Real-World Evidence Health Technology Assessment Methodological challenges Evidence-based decision-making International health systems

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